Important Regulatory Decisions Accepted for Patients with Lung Cancer

14 April 2020

GMP News

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab), administered concomitantly with a limited course of chemotherapy, for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The FDA granted this application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of August 6, 2020, in addition to granting Fast Track designation.

Additionally, the European Medicines Agency (EMA) validated a type II variation application for Opdivo plus Yervoy, combined with limited chemotherapy, for the same indication. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. This follows an announcement on March 26, 2020 that Ono Pharmaceutical Co., in partnership with Bristol Myers Squibb, submitted a supplemental application for Opdivo plus Yervoy combined with limited chemotherapy for consideration of manufacturing and marketing approval in Japan.

The applications were based on results from the Phase 3 CheckMate -9LA trial. In October 2019, the company announced the trial met its primary endpoint of superior overall survival (OS) at a pre-specified interim analysis.

“Despite treatment advances, there remains a serious unmet need for additional innovative treatment options for lung cancer patients globally,” said Sabine Maier, M.D., development lead, thoracic cancers, Bristol Myers Squibb. “The FDA’s acceptance and EMA’s validation of our applications represent important milestones for patients with lung cancer, and we look forward to working with regulatory authorities to bring the first and only dual immunotherapy plus limited chemotherapy regimen to patients as soon as possible.”

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